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Supplemental Fiber for Gut and Vascular Health in Obesity

This study is looking at whether taking a daily fiber supplement called inulin can improve the health of your gut and blood vessels if you have obesity. Researchers are also interested in whether the effects of inulin differ depending on if you have few or several risk factors for heart disease, like high blood pressure or blood sugar. You might be able to join if you are 18-55 years old, have a BMI of 30 or higher, and have either 0-1 or 2+ risk factors for metabolic syndrome (a group of conditions that increase your risk of heart disease, stroke, and type 2 diabetes). The study will measure certain proteins in your blood (sCD14, LBP, CRP) that are linked to inflammation and gut health to see if the inulin supplement makes a difference. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 20 participants. Participants will be grouped based on their metabolic health.
What's involved
You would take inulin daily for 9 weeks, starting with 6g for one week and then 12g for eight weeks. You would have three in-lab visits (at the beginning, middle, and end of the study) where blood samples, vascular measurements, and body composition will be taken after a 10-hour fast. You'll also wear a blood pressure monitor for 24 hours and complete a 3-day food record after each in-lab visit.
Compensation
Not stated in the trial record.
Follow-up
Your blood markers will be measured through study completion, up to 1.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07095426

Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes

Recruiting
NAAges 18–55Interventional
Ball State University
~20 participants
Updated 2025-07-31 on ClinicalTrials.gov
What's tested:inulin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serum Soluble Cluster of Differentiation 14 (sCD14)
Measured over Through study completion, up to 1.5 years.
+7 more outcomes measured

Conditions

Metabolic Syndrome
Healthy Participants
Metabolically Healthy Obesity
Metabolically Abnormal Obesity

Explore related trials

Metabolic SyndromeObesity

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Bryant Keirns, PhD · PRINCIPAL_INVESTIGATOR · Ball State University

Who to contact

Bryant Keirns, PhD
[email protected]
765-285-8356
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants are 18-55 years old.
Participants BMI is ≥30 kg/m2 - this BMI requirement is due to our research aims.
Participants have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.
Participants are not pregnant or expecting to become pregnant (females only). •Participants are not postmenopausal (females only).
Participants have not been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
Participants have not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, diverticulosis/diverticulitis).
Participants do not regularly take anti-inflammatory drugs (more than 2x week) and are willing to suspend use of these medications for 3 days leading up to in-lab visits.
Participants do not take weight-loss medications (e.g., Ozempic, Wegovy).
Participants do not use tobacco products or any illicit drugs.
Participants have not used antibiotics or probiotics in the last month.
Participants do not have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
Participants do not have a pacemaker.
Participants are able to lie on their back (supine position) in the dark for at least 10 minutes (related to vascular measurements).

Exclusion

Participants are not 18-55 years old.
Participants BMI is not ≥30 kg/m2 - this BMI requirement is due to our research aims.
Participants do not have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.
Participants are pregnant or expecting to become pregnant (females only).
Participants are postmenopausal (females only).
Participants have been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
Participants have been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, diverticulosis/diverticulitis). •Participants regularly take anti-inflammatory drugs (more than 2x week) and are not willing to suspend use of these medications for 3 days leading up to in-lab visits.
Participants take weight-loss medications (e.g., Ozempic, Wegovy).
Participants use tobacco products or any illicit drugs.
Participants have used antibiotics or probiotics in the last month.
Participants have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
Participants have a pacemaker.

What this trial measures

  • Serum Soluble Cluster of Differentiation 14 (sCD14)Through study completion, up to 1.5 years.

    The investigators will measure fasting sCD14 at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  • Serum Lipopolysaccharide Binding Protein (LBP)Through study completion, up to 1.5 years.

    The investigators will measure fasting LBP at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  • Serum C-Reactive Protein (CRP)Through study completion, up to 1.5 years.

    The investigators will measure fasting CRP at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  • Heart Rate Variability (HRV)Through study completion, up to 1.5 years.

    The investigators will measure HRV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  • Flow-Mediated Dilation (FMD)Through study completion, up to 1.5 years.

    The investigators will measure FMD at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  • Pulse Wave Velocity (PWV)Through study completion, up to 1.5 years.

    The investigators will measure PWV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  • Aortic AumentationThrough study completion, up to 1.5 years.

    The investigators will measure aortic augmentation at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  • Augmentation Index (AIx)Through study completion, up to 1.5 years.

    The investigators will measure AIx at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.